Does using Endocuff Vision device increase the ability to find bowel polyps in bowel cancer screening endoscopy?

The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30005319

Enrollment

3222

Registered

2017-06-16

Start date

2017-02-14

Completion date

Unknown

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology

Interventions

Participants undergo a endoscopy as per usual practice. Participants are randomly allocated to one of the groups using randomisation software, stratifying for age group and gender. Treatment arm: Par

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 55 to 61 years (both male and female) 2. Referral for screening flexible sigmoidoscopy 3. Ability to give informed consent

Exclusion criteria

Exclusion criteria: 1. Absolute contraindications to flexible sigmoidoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage) 6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure 9. Pregnancy

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure	—

Secondary

Measure	Time frame
1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure 2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure 3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure 4. Overall procedure time is measured at time of procedure 5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure 6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure 7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure 8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after 9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed 11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data	—

Measure

Time frame

1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure 2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure 3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure 4. Overall procedure time is measured at time of procedure 5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure 6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure 7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure 8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after 9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed 11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data

—

Countries

England, United Kingdom

Contacts

Public ContactMartin Walls

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026